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Improving Diabetes Care for African Americans

The Expanded Chronic Care Model: Targeting Disparities in Diabetes Care

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00436176
Enrollment
6000
Registered
2007-02-16
Start date
2007-06-30
Completion date
2008-11-30
Last updated
2009-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes mellitus, Quality of Health Care, Cultural Competency, Performance Feedback, Health navigator, Health disparities, Racial disparities

Brief summary

The goal of this study is to investigate methods of improving diabetes care for African Americans in primary care clinics. Primary care clinicians will receive training in the delivery of cross-cultural medicine as well as regular performance feedback reports.

Detailed description

Effective solutions are needed to address the parallel persistence of a quality chasm and racial disparities in diabetes care. Many large health care systems are adopting components of the Chronic Care Model to achieve substantial gains in diabetes care, though few health systems have successfully incorporated elements specific to minority health. We have previously identified racial disparities in key diabetes outcomes measures within an integrated health care delivery system, Harvard Vanguard Medical Associates (HVMA). This project will use a randomized, controlled study design within HVMA to evaluate whether enhancements to the Chronic Care Model can produce significant improvement in the quality of diabetes care for black patients. Intervention clinicians will receive monthly panel-level disparities report cards, health navigation training, and cultural competency training, while control clinicians will function within the context of the generic Chronic Care Model. The study will occur over a 12 month period and involve 4,000 white patients and 2,500 black patients with diabetes receiving care at 8 health centers. The primary outcomes will include rates of glucose (HbA1c \<7.0), LDL cholesterol (\<100 mg/dL), and blood pressure (\<130/80) control. We will use patient focus groups to identify significant barriers to care and guide health navigation training. We will survey clinicians pre- and post intervention to assess the effect of the intervention on knowledge and attitudes towards disparities. Patient experiences will be assessed pre- and post-intervention using a validated instrument to determine whether the intervention can reduce existing racial disparities in patient reports of quality. We will perform a cost analysis related to the intervention using a health system perspective. In summary, this project will provide health systems with a rigorous analysis of a defined set of tools to improve diabetes care for minority populations.

Interventions

BEHAVIORALExpanded Chronic Care Model

Intervention clinicians receive monthly performance feedback reports, cultural competency training, and health navigation training.

Sponsors

Brigham and Women's Hospital
CollaboratorOTHER
Harvard University
CollaboratorOTHER
Harvard Vanguard Medical Associates
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Diagnosis of diabetes mellitus (based on fasting glucose, HbA1c, and problem list) * At least 18 years old * At least one face-to-face visit with Harvard Vanguard primary care clinician in the last 2 years

Exclusion criteria

* Any patient not categorized as either White or Black based on race identifier in the electronic medical record

Design outcomes

Primary

MeasureTime frame
Rate of LDL cholesterol control (< 100 mg/dL)12 months
Rate of blood pressure control (< 130/80 mmHg)12 months
Rate of HbA1c control (<7%)12 months

Secondary

MeasureTime frame
Rate of HbA1c control (<8%)12 months
Rate of LDL cholesterol control (< 130 mg/dL)12 months
Rate of blood pressure control (< 140/90 mmHg)12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026